Cleared Traditional

K841168 - STERILIZATION PROCESS INDICATOR

K841168 is an FDA 510(k) clearance for STERILIZATION PROCESS INDICATOR, manufactured by Parke-Davis Co.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K841168 · Parke-Davis Co. · General Hospital
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May 1984
Decision
51d
Days
Class 2
Risk

K841168 is an FDA 510(k) clearance for the STERILIZATION PROCESS INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Parke-Davis Co. (Brookville, Ontario, CA). The FDA issued a Cleared decision on May 9, 1984 after a review of 51 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Parke-Davis Co. devices

FDA 510(k) Submission Details - K841168

510(k) Number K841168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1984
Decision Date May 09, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 201
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K841168.
STRIP, STERILIZATION INDICATOR
K890765 · Spsmedical Supply Corp. · Aug 1989
BIO-CHALLENGE TEST PAK
K851804 · Propper Mfg. Co., Inc. · Jul 1985
DART DAILY AIR REMOVAL TEST
K844512 · American Sterilizer Co. · Mar 1985
OK FLASH STERILIZATION INDICATOR
K834353 · Propper Mfg. Co., Inc. · Mar 1984
CASTLE TEC-TEST S.M.A.R.T. PACK
K833074 · Castle Co. · Nov 1983
CHEMDI STEAM & GAS STERILIZATION INDICA
K823074 · American Sterilizer Co. · Nov 1982